Hepatitis C – Assessment to Treatment Trial (HepCATT) in primary care:study protocol for a cluster randomised controlled trial
Autor: | Kirsty Roberts, William L. Irving, Peter Vickerman, Chris Metcalfe, John Macleod, Sharon Marlowe, Fiona H. Gordon, Peter Muir, Joanne Simon, Barbara Coleman, Jeremy Horwood, Matthew Hickman, Cherry-Ann Waldron, William Hollingworth, Graham I. Harrison |
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Jazyk: | angličtina |
Rok vydání: | 2016 |
Předmět: |
medicine.medical_specialty
Referral Psychological intervention Nice Medicine (miscellaneous) BTC (Bristol Trials Centre) law.invention 03 medical and health sciences Study Protocol 0302 clinical medicine Randomized controlled trial Clinical Protocols Patient Education as Topic Complex intervention law Intervention (counseling) Health care Outcome Assessment Health Care medicine Humans Pharmacology (medical) 030212 general & internal medicine Cluster randomised controlled trial Referral and Consultation HepCATT computer.programming_language Primary Health Care business.industry 030503 health policy & services Public health Case-finding Hepatitis C Chronic Primary care Hepatitis C Centre for Surgical Research Family medicine HCV Physical therapy BRTC 0305 other medical science business computer RCT |
Zdroj: | Roberts, K A, Macleod, J, Metcalfe, C, Simon, J, Horwood, J, Hollingworth, W, Marlowe, S, Gordon, F H, Muir, P, Coleman, B, Vickerman, P, Waldron, C-A, Irving, W L & Hickman, M 2016, ' Hepatitis C – Assessment to Treatment Trial (HepCATT) in primary care : study protocol for a cluster randomised controlled trial ', Trials, vol. 17, 366 . https://doi.org/10.1186/s13063-016-1501-3 Trials |
Popis: | Background Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses have been reported to PHE and of these 28,000 have been treated. Targeted case-finding in primary care is estimated to be cost-effective; however, there has been no robust randomised controlled trial evidence available of specific interventions. Therefore, this study aims to develop and conduct a complex intervention within primary care and to evaluate this approach using a cluster randomised controlled trial. Methods/design A total of 46 general practices in South West England will be randomised in a 1:1 ratio to receive either a complex intervention comprising: educational training on HCV for the practice; poster and leaflet display in the practice waiting rooms to raise awareness and encourage opportunistic testing; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit + software (BMJ Informatica). The audit will then be used to recall and offer patients a HCV test. Control practices will follow usual care. The effectiveness of the intervention will be measured by comparing number and rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer-term cost-effectiveness of the intervention in improving quality-adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Patients’ and health care workers’ experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews. Discussion This trial has the potential to make an important impact on patient care and will provide high-quality evidence to help general practitioners make important decisions on HCV testing and onward referral. If found to be effective and cost-effective the intervention is readily scalable and can be used to support the implementation of NICE recommendations on HCV case-finding. Trial registration ISRCTN61788850. Registered on 24 April 2015; Protocol Version: 2.0, 22 May 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1501-3) contains supplementary material, which is available to authorized users. |
Databáze: | OpenAIRE |
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